NCT03200470

Brief Summary

This is a prospective multicenter study. All patients presenting for revision hip or knee arthroplasty for all indications under the respective surgeon's care may be eligible. Per standard of care preoperatively, all patients must have blood drawn for erythrocyte sedimentation rate(ESR), C-reactive protein(CRP) and D-dimer. Aspiration of the joint in question may be performed at the discretion of the treating surgeon and results documented. Intraoperative samples will also be collected and sent for NGS analysis

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

12 months

First QC Date

June 20, 2017

Last Update Submit

October 11, 2017

Conditions

Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

  • NextGeneration Sequencing analysis concordance with Muskuloskeletal Infection Society (MSIS) criteria for defining infection

    MSIS criteria incorporates pre-operative laboratory values with tissue and fluid samples collected during surgery in an attempt to diagnose infection

    Immediate post-operative period (usually within 5 days following surgery)

Study Arms (1)

Suspected PJI

Other: No intervention: sample collection study

Interventions

No intervention: sample collection studyOTHER

Sample collection and collection of laboratory values

Suspected PJI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples will be collected from subjects undergoing revision for suspected infection. Data analysis will occur on samples collected

You may qualify if:

  • Patients undergoing primary total hip or knee arthroplasty with no history of prior surgery
  • Patients undergoing revision hip or knee arthroplasty for septic or aseptic indication.

You may not qualify if:

  • \. Patients undergoing second stage re-implantation surgery for PJI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Officials

  • Tiffany Morrison, MS, CCRP

    Rothman Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 27, 2017

Study Start

February 16, 2017

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

US(1)